Anesthesia Management of Coronary Artery Bypass Surgery and Inflammatory Biomarkers

June 3, 2024 updated by: Ankara City Hospital Bilkent

The Effect of Total Intravenous Anesthesia or Inhalation Anesthesia on Inflammatory Biomarkers in Coronary Artery Bypass Surgery and Their Relationship With Early Postoperative Complications a Prospective Observational Study

The goal of this observational study is to evaluate effect of total intravenous anesthesia or inhalation anesthesia on inflammatory biomarkers in coronary artery bypass surgery and their relationship with early postoperative complications. The main questions it aims to answer are

  • Does the type of anesthesia have a relationship with inflammatory biomarkers?
  • Are inflammatory biomarkers associated with postoperative complications?

Study Overview

Status

Completed

Conditions

Detailed Description

This study is planned to be a prospective observational clinical study. Patients who will undergo on-pump coronary artery bypass surgery, meet the eligibility criteria and agree to participate in the study and sign the informed patient consent form will be included in the study.Systemic immune inflammatory index, systemic inflammatory response index, neurophile lymphocyte ratio, platelet lymphocyte ratio will be calculated in the routine complete blood count of patients in the last 3 preoperative days and in the first 24 hours postoperatively.It will be evaluated whether these biomarkers are related to the anesthesia technique used, patients comorbidities and the complications that develop in the first 24 hours postoperatively. Patients will be evaluated preoperatively, intraoperatively and postoperatively; preoperative comorbidities, intraoperative anesthesia management, cross clamp, pump and surgery times, blood and blood product transfusion, inotrope use and complications that develop up to the first 24 hours postoperatively will be recorded.The anesthetic technique to be used will be determined according to the anesthesiologist's preference and will be recorded.

Study Type

Observational

Enrollment (Actual)

228

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06800
        • Ankara City Hospital Bilkent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

ASA (American Society of Anesthesiologists) II- III patients over the age of 18 who will undergo on-pump bypass surgery in Ankara City Hospital Bilkent and who agree to participate in the study

Description

Inclusion Criteria:

  • On-pump bypass surgery
  • Del-Nido cardioplegia used in operation
  • ASA (American Society of Anesthesiologists) II- III patients

Exclusion Criteria:

  • Patients with active malignancy
  • Diagnosed with systemic inflammatory disease or autoimmune disease
  • Chronic liver and kidney disease
  • History of cerebrovascular disease within 6 months
  • EF (Ejection Fraction) < 45%
  • Non-cooperative or patients who do not agree to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Inhalation Anesthesia Group
After induction, anesthesia will be provided with sevoflurane (2.0 mac) and intravenous remifentanil infusion (0.05-0.2 mcg/kg/min). Depth of anesthesia will be evaluated with Bispectral Index (BIS).
Total Intravenous Anesthesia Group
After induction, anesthesia will be provided with intravenous propofol infusion (50-150 mcg/kg/min) and intravenous remifentanil infusion (0.05-0.2 mcg/kg/min). Depth of anesthesia will be evaluated with Bispectral Index (BIS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative systemic immune inflammatory index (SII)
Time Frame: within 3 days preoperatively
It will be calculated as: platelet count x neutrophil count / lymphocyte count from routine complete blood count
within 3 days preoperatively
Preoperative systemic inflammatory response index (SIRI)
Time Frame: within 3 days preoperatively
It will be calculated as: neutrophil count x monocyte count/lymphocyte count from routine complete blood count
within 3 days preoperatively
Postoperative systemic inflammatory response index (SIRI)
Time Frame: in the first 24 hours postoperatively
It will be calculated as: neutrophil count x monocyte count/lymphocyte count from routine complete blood count
in the first 24 hours postoperatively
Preoperative neutrophile lymphocyte ratio (NLR)
Time Frame: within 3 days preoperatively
It will be calculated as:neutrophil count/lymphocyte count from routine complete blood count
within 3 days preoperatively
Postoperative neutrophile lymphocyte ratio (NLR)
Time Frame: in the first 24 hours postoperatively
It will be calculated as:neutrophil count/lymphocyte count from routine complete blood count
in the first 24 hours postoperatively
Preoperative platelet lymphocyte ratio (PLR)
Time Frame: within 3 days preoperatively
It will be calculated as: platelet count/lymphocyte count from routine complete blood count
within 3 days preoperatively
Postoperative platelet lymphocyte ratio (PLR)
Time Frame: in the first 24 hours postoperatively
It will be calculated as: platelet count/lymphocyte count from routine complete blood count
in the first 24 hours postoperatively
Postoperative complications
Time Frame: within the first 24 hours after surgery

Postoperative complications consisting of:

  • newly developed atrial fibrillation
  • need for cardiac pacing
  • need for ECMO (Extracorporeal membrane oxygenation)
  • need for IABP (Intra-Aortic Balloon Pump)
  • prolonged mechanical ventilation
  • pericardial effusion
  • cardiac arrest
  • cerebrovascular event
  • delirium
  • exitus
  • other complications.
within the first 24 hours after surgery
Postoperative systemic immune inflammatory index (SII)
Time Frame: in the first 24 hours postoperatively
It will be calculated as: platelet count x neutrophil count / lymphocyte count from routine complete blood count
in the first 24 hours postoperatively
Preoperative c-reactive protein
Time Frame: within 3 days preoperatively
from routine preoperative blood sample ( milligram/decilitre)
within 3 days preoperatively
Preoperative procalcitonin
Time Frame: within 3 days preoperatively
from routine preoperative blood sample ( microgram/litre)
within 3 days preoperatively
Postoperative c-reactive protein
Time Frame: in the first 24 hours postoperatively
from routine postoperative blood sample ( milligram/decilitre)
in the first 24 hours postoperatively
Postoperative procalcitonin
Time Frame: in the first 24 hours postoperatively
from routine postoperative blood sample ( microgram/litre)
in the first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient comorbidities
Time Frame: preoperative within 48 hours
Patient comorbidities will be assessed
preoperative within 48 hours
Transfusion requirement
Time Frame: during the operation
Incidence of transfusion of blood and blood products to the patient
during the operation
Inotrope requirement
Time Frame: during the operation

Incidence of inotrope usage, inotropes consisting of:

  • noradrenaline
  • dopamine
  • dobutamine
during the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • volgaozkan1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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